Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 29, 2025 has been entered.
DETAILED ACTION
The instant application has provisional application 63/160452, filed March 12, 2021 and is a CON of PCT/US22/20075 filed March 11, 2022.
Applicant’s Amendment filed December 29, 2025 is acknowledged. Claims 2-4, 10, 12, 14-18, 20-21, and 25-95 are canceled, and claims 1 and 9 are amended. Currently claims 1, 5-9, 11, 13, 19, and 22-24 are pending and under examination.
The previous 103 rejection is withdrawn in the Final office action mailed August 26, 2025 due to Applicant’s amendment to the claims and remarks filed December 29, 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-9, 11, 13, 19, and 22-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating age-related macular degeneration (AMD) by directly administering a composition consisting of 6-10 microbial strains at a concentration of 101 to 1015 CFU, comprising Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve to a subject in need thereof via an ocular route of administration, does not reasonably provide enablement for administering the composition at any concentration via any route as a method for treating AMD. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The breadth of the claims:
Claims 1, 5-9, 11, 13, 19, and 22-24 are drawn to method for treating AMD by administering to an individual in need thereof a composition comprising G. hansenii, T. glycolicus, C. catus, L. plantarum, V. atypica, and B. breve. The breadth of the claims encompass administering via any route to treat AMD. The specification discloses the routes of administration may be ocular, oral, parenteral, topical, etc., and the concentrations of each species in the composition can be 101 to 1015 CFU.
The nature of the invention:
The nature of the invention relies upon administering the recited composition to a subject in need thereof via an ocular route of administration wherein the composition mitigates macular degeneration of affected cells of the eye.
The state of the prior art:
Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification.
A thorough review of the patent and non-patent literature indicates that the state of the art demonstrating administering the recited composition via any route at any concentration as a method for treating an eye disorder (AMD) is lacking and variable at best. Heydari et al. (Probiotics and Antimicrobial Proteins (2024) 16:1026–1035) discloses a recent study evaluating the effects of ophthalmic and systemic formulations of Latilactobacillus sakei in treating patients with dry eye disease (DED), and found no significant improvement of signs or symptoms of DED were seen via administration of capsules as compared to administration of the probiotic ophthalmically (abstract). Heydari et al. further discloses other oral administration of probiotics for treating DED, which had varying effects of improvements, and pointed out that their results should not be seen as a direct contradiction of the studies commented on above, as many probiotic characteristics are species or strain-specific (pg. 1033, col. 1, para 2).
A review of the gut-eye axis for ocular diseases by Campagnoli et al. (Int. J. Mol. Sci. 2023, 24, 13338, pgs. 1-30) disclose the relationship between intestinal dysbiosis and the onset of AMD is currently under investigation, given that the number of the available clinical studies is still limited, however evidence does see correlation of a reduced Firmicutes/Bacteroides ratio that seems to characterize AMD across the different studies (pg. 7). Campagnoli et al. underscores the need for further investigations on the interplay among gut microbiota (GM), GM-derived metabolites, and AMD are mandatory; moreover, managing GM composition with alternative strategies could be useful for lowering the risk of progression at the early stages of the disease (pg. 7).
Thus, a review of the prior art does not find a strong correlation between administration of probiotics via any route to treat eye disorders, specifically AMD, from the full scope of the claims, and the prior art underscores the variability of ocular and gut microbiota in their effect on eye disorders.
The level of one of ordinary skill and predictability in the art:
While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that methods for treating AMD administering the recited composition via any route or concentration, one of ordinary skill in the art would look for guidance or direction in the instant specification.
The working embodiment in the instant application describes using microbiome therapies in-vitro, each comprising various combinations of microbial strains (i.e. the claimed composition) at a concentration of 106 CFU and metabolites, on degraded retinal-ARPE-19 cells. The working embodiments do not describe any other microbiome therapies administered in-vivo via any other route of administration at any other concentrations. While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The prior art is undeveloped for the role that the claimed probiotic composition administered via any route at any concentration plays in treating AMD, and given the broad scope of the claims and different variables of treatment encompassed, it is unpredictable if administering the claimed composition via any route other than ocularly, would reasonably treat AMD. The prior art also does not provide additional guidance to enable treating the full scope of the claims.
Therefore, due to the unpredictability in the art with respect to administering the claimed composition via any route at any concentration to treat AMD of the full scope of the claimed method, one would have to engage in experimentation that is not reasonable in order to determine which variables could be employed by treating with the recited composition.
Without further guidance, one of skill in the art would have to practice a substantial amount of trial-and-error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5-9, 11, 13, 19, and 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a composition consisting of six to ten microbial strains, wherein the microbial strains comprises Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve. The term “consisting of” is a close-ended transitional term, which is followed by an open-ended transitional term “comprises”, thus, it is unclear whether any other unrecited strains are included in the claimed composition; and if permitted, whether up to four unrecited strains are included in the claimed composition. Claims 5-9, 11, 13, 19, and 22-24 are likewise rejected as being dependent on an indefinite claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-9, 11, 13, 19, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11957723B2 (‘723) in view of Volpe et al. (Trans Am Ophthalmol Soc. 2015;113:T12, hereinafter “Volpe”).
Claims 1-13 of ‘723 recite a method of treating or preventing amyotrophic lateral sclerosis (ALS) comprising administering to a subject in need thereof a composition comprising the composition recited in instant claim 1. The method recited by ‘723 further recites the subject is mammal, human, comprises 6-10 microbial strains, administered various routes, formulated in various formulations, and wherein each microbial strain is present at a concentration of 101 to 1015 CFU.
‘723 does not recite the composition is used in a method for treating AMD.
However, Volpe teaches ophthalmic manifestations of amyotrophic lateral sclerosis (ALS), and correlates decreasing macular thickness (i.e. degeneration) with ALS disease duration (abstract). Volpe discloses age-related neurodegenerative disease macular degeneration remains the focus of ophthalmologists, and confirms ocular involvement in patients with ALS (pg. 2, para 2; abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of treating ALS with the claimed composition recited in ‘723, and further treat AMD as an ALS disease progression factor as taught by Volpe with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to evaluate the composition’s effectiveness in treating age-related neurodegenerative disease macular degeneration to arrive at the instantly claimed method.
Claims 1, 5-9, 11, 13, 19, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-10, 22-27, and 149-152 of copending Application No. 18/073511 in view of Volpe.
Claims 1, 4, 6-10, 22-27, and 149-152 of ‘511 recite a method of improving a Vagus nerve-associated disease, wherein the disease is ALS, comprising administering to a subject in need thereof a composition comprising the composition recited in instant claim 1. The method recited by ‘511 further recites the subject is mammal, human, comprises 6-10 microbial strains, administered various routes, formulated in various formulations, and wherein each microbial strain is present at a concentration of 101 to 1015 CFU. ‘511 does not recite the composition is used in a method for treating AMD.
However, Volpe teaches ophthalmic manifestations of amyotrophic lateral sclerosis, and correlates decreasing macular thickness (i.e. degeneration) with ALS disease duration (abstract). Volpe discloses age-related neurodegenerative disease macular degeneration remains the focus of ophthalmologists, and confirms ocular involvement in patients with ALS (pg. 2, para 2; abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of improving ALS with the claimed composition recited in ‘511, and further treat AMD as an ALS disease progression factor as taught by Volpe with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to evaluate the composition’s effectiveness in treating age-related neurodegenerative disease macular degeneration to arrive at the instantly claimed method.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5-9, 11, 13, 19, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 38, 40-43, 51, and 53 of copending Application 17/472189 (Notice of Allowance issued, U.S. Patent pending). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 34, 51, and 53 of ‘189 recite a composition comprising the recited species of instant claims 1 and 13, wherein the composition is an ingestible item. Although the claims of ‘189 do not recite a method of treating AMD, the specification of ‘189 discloses the composition can be used for treating AMD [0121], thus the instantly claimed method of treatment utilizing the composition recited in ‘189 would be obvious, therefore not patentably distinct.
Claims 1, 5-9, 11, 13, 19, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-71 and 85-95 of copending Application No. 17/673581.
Regarding instant claims 1 and 13, claims 63-70 and 85-87 of ‘581 recites the composition comprises Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus sp., L. plantarum, Clostridium butyricum, Paenibacillus sp., Veillonella sp., Bifidobacterium sp., Bacillus subtilis, Acidaminococcus sp., inter alia, or a combination thereof. The claims of ‘581 do not explicitly recite a method for treating age-related macular degeneration. Although the claims of ‘581 do not recite a method of treating AMD, the specification of ‘581 discloses the composition can be used for treating AMD [0033], thus the instantly claimed method of treatment utilizing the composition recited in ‘581 would be obvious, therefore not patentably distinct.
Regarding instant claims 23 and 24, claims 88-95 recite the composition comprises 101 to 1015 CFUs of each microbial strain in the claimed compositions of ‘581.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed December 29, 2025, with respect to claims 1, 5-9, 11, 13, 19, and 22-24 have been fully considered and are persuasive. The U.S.C. 103 rejection of claims 1, 5-9, 11, 13, 19, and 22-24 has been withdrawn.
Regarding the provisional Double Patenting Rejection, Applicant requests these be held in abeyance until a determination of allowable subject matter (Remarks p. 6). A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejection of record have been maintained as no response to these rejections has been filled by applicant at this time.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657